PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
FDA 510(k) clearance K070594 · decided 2007-08-01
Clearance details
- K-number
- K070594
- Device name
- PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
- Applicant
- Pulmonetic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-02
- Decision date
- 2007-08-01
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on p recall (Z-2593-2014) | CareFusion 203, Inc. | 2014-09-19 |
| CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or recall (Z-2006-2012) | CareFusion 203, Inc. | 2012-07-16 |
| CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch recall (Z-0074-2012) | CareFusion 203, Inc. | 2011-10-26 |
| Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapo recall (Z-0857-2010) | CareFusion 203, Inc. | 2010-02-25 |